A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Children (6 to < 12 Years Old) With Nonsegmental Vitiligo

Sponsor
Incyte Corporation
Study ID
NCT06804811
Phase
PHASE3
Status
Recruiting
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Conditions

  • NonSegmental Vitiligo

Eligibility Criteria

Sex
ALL
Age
6 Years - 11 Years
Healthy Volunteers
Not accepted

Interventions

  • Ruxolitinib Cream — DRUG
    Ruxolitinib cream applied topically to the affected area as a thin film twice daily.
  • Vehicle Cream — DRUG
    Matching vehicle cream applied topically to the affected area as a thin film twice daily.

Study Details

The purpose of this study is to evaluate the efficacy and safety of ruxolitinib cream in children (6 to \< 12 years old) with nonsegmental vitiligo.

Key Dates

Start date
Nov 13, 2025
Status verified
Dec 2025
Primary completion
Apr 30, 2027
Completion
Dec 1, 2027

Study Design

Enrollment
250 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ruxolitinib 0.75 % Cream
    Participants received ruxolitinib 0.75% cream, applied topically to the affected area as defined in the protocol.
  • Experimental: Ruxolitinib 1.5 % Cream
    Participants received ruxolitinib 1.5% cream, applied topically to the affected area as defined in the protocol.
  • Placebo Comparator: Vehicle Cream
    Participants received vehicle cream, applied topically to the affected area as defined by the protocol.

Primary Outcome Measure

Proportion of Participants Achieving a ≥ 75% Improvement From Baseline in the Facial Vitiligo Area Scoring Index (F-VASI75) [ Time Frame: Week 24 ]

Central Contacts

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